PA Consulting Group continues to lead in product compliance management and medical device design, and understands the true impacts of regulatory change.
Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) provides the current regulatory framework for placing in vitro diagnostic (IVD) products on the EU market. The IVDD has been in its present form since 1998 and has not kept pace with state of the art regulatory requirements and developments in IVD related technologies.
The IVDD establishes essential requirements and conformity assessment procedures that manufacturers and authorised representatives need to comply with to ensure the efficacy, quality and safety of their products. For certain devices (about 20% of IVDs) an independent third party (Notified Body) is involved in the assessment of compliance prior to the manufacturer placing a CE marking of conformity on the product.
The new EU IVD Regulation will implement major changes in the regulatory processes for IVD products. Most IVD manufacturers intending to launch new products within the EU or retain existing products, it is necessary to start gap analysis and planning against the new IVD Regulation as soon as possible. Indeed, some IVD devices may not remain viable or practicable under the new Regulation.
With complete change in the IVD device classification system and conformity assessment processes, the impact of the IVD Regulation is in many cases far reaching on manufacturers. Around 80% of IVD products will now require a Notified Body, and many manufacturers will need to improve their QMS processes and technical documentation for CE marking. Clinical evidence, and device vigilance processes are each undergoing significant change. Responsibilities for a newly defined range of ‘economic operators’ will provide legal impact on supplier management and partnering contracts.
Some of the key changes are:
- Classification of IVDDs will have four risk based levels (A, B, C, D) with D highest risk. Examples: self-test Blood Glucose Meter (BGM) devices will be Class C, highest risk IVD Assays will be Class D, general IVD Instrumentation will stay Class A
- New definitions and responsibilities for a range of ‘Economic Operators’, new requirements on legal contacts
- Manufacturers, and other types of ‘Economic Operators’, will need to employ at least one ‘Qualified Person’, a new regulatory role defined in the Regulation
- A Unique Device Identification (UDI) system will be introduced starting with highest risk devices
- Web marketed IVD products purchasable on the EU market (including those distributed outside of EU) will need to comply with the new IVD Regulation
- Clinical evidence required to be accumulated and assessed throughout the market lifetime of the device
- Vigilance procedures will require trend reporting for some classes of IVD device.
To discuss how PA can help you with the challenges of regulatory change in both the IVD medical product and process contexts, please contact us now.